To complement recent increases in commercial manufacturing capacity, the Chasse-sur-Rhône site is further expanding its development capabilities with a new investment for its Pilot workshop. Jean-Pierre Pilleux, Site Director, explains.

What are we talking about when we talk about the Chasse-sur-Rhône Pilot workshop?

The Pilot workshop is a multi-stream facility where we manufacture APIs for both clinical & commercial supply. With the trend towards lower volume drugs for targeted therapies, the Pilot offers both the capacity and flexibility required for commercial manufacturing. In parallel the Pilot continues to fulfil its traditional role for scale-up and supply of clinical products. 

How does this new investment fit into the site’s overall development plan?

Six new APIs manufactured on site have been approved by the FDA in 2018 & 2019, and the site is rapidly evolving. The investment we have just completed at the Pilot workshop represents a budget of €1 million & is part of an ongoing investment program which, taken over 5 years, amounts to €20 million. This considerable sum was allocated to renewing our industrial tool and extending it in a targeted way to respond to new market opportunities.

How is this new investment materialized?

The new investment aims to maximize the use of the equipment installed at the Pilot workshop to meet customer requirements. To this end, at the end of 2016, we decided to build an extension to the existing “Pilot” by adding a 45m² clean room. This one is equipped with a new filter dryer and we replaced a small reactor with a larger and much more versatile unit. This reactor is made of Hastelloy, a corrosion-resistant steel alloy, and can also be used at very low temperatures. With this targeted investment, we will improve our flexibility and have the option to “pilot” up to 3 processes in parallel.

Let’s look back at the project a little bit; how did it unfold?

We started the project in 2017, with a real acceleration of the work in 2018. Many employees have participated in this project and I would like to thank them all for their involvement. Their contribution was essential to the realization of this project, which was carried out in parallel with other major projects and without disrupting production at the workshop. It was a great success.

New Hastelloy reactor

New clean room

Learn more about Novasep CDMO services for APIs or meet us at CPhI WW at booth 101B10!